Assessment of Relative Bioavailability and Effect of Food on Capsule and Tablet Formulations of TP-3654 - Trial NCT06389955
Access comprehensive clinical trial information for NCT06389955 through Pure Global AI's free database. This Phase 1 trial is sponsored by Sumitomo Pharma America, Inc. and is currently Completed. The study focuses on Healthy. Target enrollment is 12 participants.
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Study Focus
Sponsor & Location
Sumitomo Pharma America, Inc.
Timeline & Enrollment
Phase 1
May 22, 2023
Aug 24, 2023
Primary Outcome
Part A - The maximum concentration (Cmax) of TP-3654 in a capsule formulation,Part A - The area under the curve (AUC) of TP-3654 in a capsule formulation,Part A - Ratio of Peak Plasma Concentration (Cmax) of TP-3654 tablet versus TP-3654 capsule under fasted conditions,Part B - The maximum concentration (Cmax) of TP-3654 in a tablet formulation
Summary
This study comprised of 2 parts, Part A and Part B. Part B will only be conducted if the
 relative bioavailability of the tablet formulation was at least 70% of the capsule
 formulation.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06389955
Non-Device Trial